BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1440416 · Received August 14, 2009

    Report

    Report Number
    2024168-2009-01475
    Event Type
    Injury
    Date Received
    August 14, 2009
    Date of Event
    June 28, 2009
    Report Date
    June 29, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISSECTION, AS LISTED IN THE XIENCE V IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS. THE IFU STATES: IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE DOES NOT APPEAR TO BE AN INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE 2.75 X 23 MM XIENCE V (LOT# 8120841), HAS BEEN FILED UNDER MFR# 2024168-2009-01314.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT WHILE USING THE 2.75 X 23 MM XIENCE V A DISSECTION OCCURRED. THE 2.75 X 28 MM XIENCE V STENT WAS USED TO COVER THE DISSECTION, BUT FURTHER DISSECTION OCCURRED. A THIRD XIENCE V STENT WAS IMPLANTED TO TREAT THIS DISSECTION. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9021941

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention GUIDE WIRE: BMW| (LOT 8120841)| STENT: 2.75 X 23 MM XIENCE V